- Otulfi® has been approved by Health Canada for subcutaneous and intravenous formulations for the treatment of severe inflammatory diseases
- Health Canada joins FDA and European Commission in granting regulatory approval for FYB202
- The earliest date for commercialization of Otulfi® in Canada is set out in a confidential settlement agreement between Formycon, Fresenius Kabi and Johnson & Johnson signed in March 2024
Planegg-Martinsried, Germany - Formycon AG (FWB: FYB, Prime Standard, "Formycon") and its distribution partner Fresenius Kabi announce that Health Canada has issued a Notice of Compliance (NOC) for FYB202/Otulfi®1 (ustekinumab), a biosimilar to Stelara®2. This approval applies to subcutaneous and intravenous formulations for the treatment of adult patients with moderate to severe active Crohn's disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. Both the US Food and Drug Administration (FDA) and the European Commission had already granted marketing authorization for FYB202 in September 2024.